510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K093999 | Arp Pov Sport | Arp Manufacturing, Inc. | NGX | Class II | |
| K093771 | Quantum/streamline Tl Mis Spinal System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | MNH | Class II | |
| K102005 | Allura Xper or Table Series | Philips North America LLC | OWB | Class II | |
| K101452 | Capintec Crc 55T Series Dose Calibrators, Models Crc 55Tr, Crc 55Tpet and Crc 55Tw | Mirion Technologies (Capintec), Inc. | KPT | Class II | |
| K101134 | Visian Nanopoint 2.0 Injector Model Lp604430 | Medicel AG | MSS | Class I | |
| K101122 | Benz-G 4X (Hioxifilcon D) Multifocal Lathed Lens | Benz Research and Development LLC | LPL | Class II | |
| K101000 | Wellmien Surgical Mask | Wellmien (Suzhou) Import & Export Trading Co., Ltd. | FXX | Class II | |
| K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | FRO | Unclassified | |
| K100887 | Versitomic Acl Flexible Reamer System Sterilization Tray | T.A.G. Medical Products Corporation Ltd | KCT | Class II | |
| K091090 | Digital Flat Panel X-Ray Detector, Model Xmaru 1717 | E-Woo Technology | MQB | Class II | |
| K101212 | Medtronic Contour 3D Annuloplasty Ring, Model 690R | Medtronic, Inc. | KRH | Class II | |
| K102117 | Tissu Trans Filtron Syringe Fill | Summit Medical, LLC | MUU | Class II | |
| K102081 | Endoscopic Clip System | Aesculap Inc | FZP | Class II | |
| K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II | |
| K102022 | Wildcat 6F Guidewire Support Catheter Model W400l and W400s | Avinger, Inc. | DQY | Class II | |
| K102001 | Modification to Renasys Ez Plus Negative Pressure Wound Therapy | Smith & Nephew, Inc. | OMP | Class II | |
| K101915 | Vasopress Supreme Mini Model Vp500dm | Compression Therapy Concepts, Inc. | JOW | Class II | |
| K101877 | Occlusion Balloon Catheter Model Obc | Cook Inc. | DQY | Class II | |
| K101647 | Wildcat 5F Guidewire Support Catheter, Mode W500 | Avinger, Inc. | DQY | Class II | |
| K101595 | Powder Free Nitrile Patient Examination Gloves, Blue | Better Care Plastic Technology Cp., Ltd. | LZA | Class I | |
| K101591 | Stingray Orienting Balloon Catheter | Boston Scientific Corporation | DQY | Class II | |
| K101542 | Headway 17 Advanced Microcatheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K101508 | Modification to Iba Proton Therapy System-Proteus 235 | Ion Beam Applications S.A. | LHN | Class II | |
| K101141 | Seiler Colposcope, Models 935, 955 and 985 | Seiler Precision Microscopes | HEX | Class II | |
| K100963 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Hebei Shenzichen Plastic & Rubber Products Co., LT | LYZ | Class I | |
| K100935 | Lanx Spinal Fixation System | Lanx, Inc. | NKB | Class II | |
| K100376 | Everon Central Display Station - Cds, Model Version 1.0.0 | Earlysense, Ltd. | MSX | Class II | |
| K094021 | Acculis Accu2i Pmta Applicator Model Accu2i | Microsulis Medical Limited | NEY | Class II | |
| K093920 | Busse Epidural Catheter Kit | Busse Hospital Disposables | BSO | Class II | |
| K093879 | Mission Saliva Alcohol Test Strip | Acon Laboratories, Inc. | DIC | Class II | |
| K092686 | Abl90 Flex Series | Radiometer Medical ApS | CEM | Class II | |
| K092029 | Ventstar Resuscitaire, Model Mp00311, Ventstar Resuscitaire Ceu, Model Mp00310 | Draeger Medical AG & Co. KG | BYE | Class II | |
| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping Insulated and Rat Tooth Forceps | Boston Scientific Corporation | OCZ | Class II | |
| K100952 | Modification to Synthes Matrix System | Synthes GmbH | NKB | Class II | |
| K100820 | Wenzel Spine Varilift Interbody Fusion System | Wenzel Spine | MAX | Class II | |
| K100382 | Salutunnel Nerve Protector, Model Ed-20329, Ed-20330, Ed-20331 | Salumedica, LLC | JXI | Class II | |
| K093868 | I.t.s. Lrs Locking Reconstruction System | I.T.S. Implantat-Technologie-Systeme GmbH | HRS | Class II | |
| K093322 | Multi-Purpose Health Device | Upc Medical Supplies, Inc. dba United Pacific Co. | BWK | Unclassified | |
| K102028 | Neotract Anchor System Model Tas400 | Neotract Inc | GAT | Class II | |
| K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro 4000 Series, 6022790-Irt 4000 Se | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | FLL | Class II | |
| K101503 | Dusimetry Check | Math Resolutions, LLC | IYE | Class II | |
| K101391 | Scandia-45 Gamma Camera System | Scandia Corporation | IYX | Class I | |
| K101361 | Reeflex Pta Catheter | Clearstream Technologies Ltd. | LIT | Class II | |
| K101279 | Corridor4dm V2010 Model: V2010 | Invia | LLZ | Class II | |
| K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | DXN | Class II | |
| K100879 | Contralco | Contralco | DJZ | Class I | |
| K093206 | Orthomap 3D 1.1 Module | Stryker Corp. | OLO | Class II | |
| K091529 | Icad Veralook Ctc Cad Software | iCAD, Inc. | JAK | Class II | |
| K101387 | Digital Thermometer, Models Bt-A11cn, Bt-A21cn, Bt-A41cn | Fudakang Industries Co., Ltd. | FLL | Class II | |
| K101289 | Scanx D5000 Series Scanner Model: D5000-F, D5000-Fb, D5000-Fvb, D5000-Q, D5000-Qb | Air Techniques, Inc. | MQB | Class II |